NENCA Study on Neurological Complications of Long COVID-19 in Children and Adolescents; Neurophysiological, Electroencephalographic and Neuroradiological Investigation

Not Applicable

Recruiting

• Conditions: Long Covid-19

• Registration Number: NCT06876948
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

Brief Summary

The study seeks to investigate the neurological effects caused by Covid-19 in children and adolescents in the 6-16 age group. To do this, neuropsychological scales, an EEG and an MRI were used.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-29
• Study First Submitted: 2025-02-19
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-14
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-03-29
• Study Completion: 2026-04-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age between 6 years and 16 years and 11 months
• Symptomatology compatible with long neurological COVID, specifically: persistence or appearance of new neurological signs/symptoms (e.g. fatigue, headache, sleep disturbance, cognitive dysfunction, memory difficulties, emotional or mood disorders, vertigo cognitive dysfunction, memory difficulties, emotional or mood disorders, dizziness, dysautonomia, movement disorders movement disorders, ataxia, tremor, epilepsy, muscle weakness, myalgia, hyposmia, hypogeusia hearing loss or tinnitus and/or sensorimotor deficits such as hypoesthesia, dysesthesia) after three months after established SARS-CoV-2 infection, as well as persistence of these symptoms for at least two months, in the absence of a clear aetiology.
• Signature of the appropriate Informed Consent by caregiver(s) and patient(s)

Exclusion Criteria

• Poor knowledge of the Italian language or other limitation of verbal communication that compromises the subject's ability to perform neuropsychological tests
• Need for sedation to perform brain MRI 7 Tesla
• Neurological or neuropsychiatric disorder diagnosed prior to COVID-19 diagnosis
• Caregiver's failure to sign consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Changes in cognitive and neuropsychological functions in children and adolescents with Long COVID between T0 and T1.	Test administration at the time of diagnosis of Long COVID (T0) and follow-up after 6-9 months (T1).	Assessment of cognitive, neuropsychological and adaptive skills in children and adolescents with Long COVID by means of standardised tests (WISC-IV, CPT3, NEPSY II, BRIEF-2, Vineland Adaptive Behavior Scales). The tests measure attention, memory, executive functions, intellectual-adaptive functioning and quality of life.

Trial Locations

Locations (1)

Azienda Ospedaliera Universitaria Pisana; 🇮🇹 Pisa, PI, Italy